FDA Inspection
WESTERN BOTANICALS FL, LLCWESTERN BOTANICALS FL, LLC – FDA Inspection, Mar 12, 2025
Record Details
This FDA Inspection record concerns WESTERN BOTANICALS FL, LLC, with an inspection on March 12, 2025, issued by the Denver District Office, covering foods & cosmetics.
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ID · 5e8e03fe-d4a1-4d99-9fde-bacff82064ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263568
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.10(b)Hygienic practices
- 21 CFR 111.155(c)(3)Quality control - components, approve, release
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.105(h)Quality control - production, process control
- 21 CFR 111.77(b)Specifications not met - identity; component, reject
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